NCT05497492

Brief Summary

the frequency of tussis, nausea and vomiting, and/or body movements observed at the insertion of the endoscope into the pharyngeal cavity or within 5 min of endoscope insertion.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 19, 2022

Completed
23 days until next milestone

First Posted

Study publicly available on registry

August 11, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

November 5, 2022

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2023

Completed
Last Updated

October 10, 2023

Status Verified

March 1, 2023

Enrollment Period

1.2 years

First QC Date

July 19, 2022

Last Update Submit

October 8, 2023

Conditions

Anesthesia

Keywords

gastroscopyesketaminesufentanillidocainepropofoltussis

Outcome Measures

Primary Outcomes (1)

  • the frequency of tussis, nausea and vomiting, and/or body movements observed at the insertion of the endoscope into the pharyngeal cavity or within 5 minutes of endoscope insertion.

    the frequency of tussis

    an average of 5 minutes，at the insertion of the endoscope into the pharyngeal cavity or within 5 minutes of endoscope insertion

Secondary Outcomes (5)

  • recovery time

    an average of 30 minutes，the time from withdrawal of endoscopy to obeying verbal commands

  • propofol dosage during operation

    through study completion, an average of 20 minutes，the time from insertion endoscopy to withdrawal of endoscopy

  • incidence of perioperative adverse events

    through study completion, an average of 1 year，the time from insertion endoscopy to withdrawal of endoscopy

  • incidence of postoperative adverse events

    through study completion, an average of 1 year，

  • MMSE scores after operation

    through study completion, an average of 1 year after operation

Study Arms (4)

P group

ACTIVE COMPARATOR

single administration of propofol

Drug: propofol

P + S group

EXPERIMENTAL

administration of propofol and sufentanil in combination

Drug: propofol and sufentanil

P + K group

EXPERIMENTAL

administration of propofol and esketamine in combination

Drug: propofol and esketamine

P + L group

EXPERIMENTAL

administration of propofol and lidocaine in combination

Drug: propofol and lidocaine

Interventions

propofolDRUG

single administration of propofol

Also known as: P
P group
propofol and sufentanilDRUG

administration of propofol and sufentanil in combination

Also known as: P+S
P + S group
propofol and esketamineDRUG

administration of propofol and esketamine in combination

Also known as: P+K
P + K group
propofol and lidocaineDRUG

administration of propofol and lidocaine in combination

Also known as: P+L
P + L group

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • undergoing diagnostic upper GI endoscopy under deep propofol sedation
  • \>18 year old
  • meeting the classification I-III of American Society of Anesthesiologists (ASA)
  • getting written informed consent

You may not qualify if:

  • allergic reaction to planned medication
  • gravis myasthenia
  • history of psychological problems or psychiatric disease
  • morbid obesity/obstructive sleep apnea
  • acute upper respiratory infections
  • asthma at acute stage
  • history of unregulated or malignant hypertension
  • history of significant ischemic heart disease or severe arrhythmia
  • severe liver or kidney dysfunction or coagulation disorders
  • acute upper GI haemorrhage with shock
  • severe anaemia
  • GI obstruction with gastric retention
  • seizure disorders
  • long-term history of sedative and analgesic drug use
  • increased intracranial pressure.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Friendship Hospital, Capital Medical University

Beijing, Beijing Municipality, 100050, China

RECRUITING

Related Publications (8)

  • Triantafillidis JK, Merikas E, Nikolakis D, Papalois AE. Sedation in gastrointestinal endoscopy: current issues. World J Gastroenterol. 2013 Jan 28;19(4):463-81. doi: 10.3748/wjg.v19.i4.463.

    PMID: 23382625RESULT

  • Canning BJ. Afferent nerves regulating the cough reflex: mechanisms and mediators of cough in disease. Otolaryngol Clin North Am. 2010 Feb;43(1):15-25, vii. doi: 10.1016/j.otc.2009.11.012.

    PMID: 20172253RESULT

  • Wehrmann T, Triantafyllou K. Propofol sedation in gastrointestinal endoscopy: a gastroenterologist's perspective. Digestion. 2010;82(2):106-9. doi: 10.1159/000285554. Epub 2010 Apr 21.

    PMID: 20407257RESULT

  • Byrne MF, Chiba N, Singh H, Sadowski DC; Clinical Affairs Committee of the Canadian Association of Gastroenterology. Propofol use for sedation during endoscopy in adults: a Canadian Association of Gastroenterology position statement. Can J Gastroenterol. 2008 May;22(5):457-9. doi: 10.1155/2008/268320.

    PMID: 18478130RESULT

  • Ho WM, Yen CM, Lan CH, Lin CY, Yong SB, Hwang KL, Chou MC. Comparison between the recovery time of alfentanil and fentanyl in balanced propofol sedation for gastrointestinal and colonoscopy: a prospective, randomized study. BMC Gastroenterol. 2012 Nov 21;12:164. doi: 10.1186/1471-230X-12-164.

    PMID: 23170921RESULT

  • Poulos JE, Kalogerinis PT, Caudle JN. Propofol compared with combination propofol or midazolam/fentanyl for endoscopy in a community setting. AANA J. 2013 Feb;81(1):31-6.

    PMID: 23513321RESULT

  • Zhang L, Bao Y, Shi D. Comparing the pain of propofol via different combinations of fentanyl, sufentanil or remifentanil in gastrointestinal endoscopy. Acta Cir Bras. 2014 Oct;29(10):675-80. doi: 10.1590/s0102-8650201400160008.

    PMID: 25318000RESULT

  • Hou HJ, Liu L, Tian M, Xue FS. Comparison of the effects of esketamine, sufentanil, or lidocaine combined with propofol on tussis reflection during upper gastrointestinal endoscopy: study protocol for a randomised, two centre, three-blind, controlled trial. Trials. 2024 Jan 4;25(1):24. doi: 10.1186/s13063-023-07812-0.

    PMID: 38178168DERIVED

MeSH Terms

Interventions

PropofolSufentanilEsketamineLidocaine

Intervention Hierarchy (Ancestors)

PhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsFentanylPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsAcetanilidesAnilidesAmidesAniline CompoundsAmines

Study Officials

  • Haijun Hou, MD

    Beijing Friendship Hospital

    STUDY CHAIR

Central Study Contacts

Haijun Hou, MD

CONTACT

+8618612568228lumen208@foxmail.com

Lu Liu, MD

CONTACT

+8618618418228503030150@qq.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 19, 2022

First Posted

August 11, 2022

Study Start

November 5, 2022

Primary Completion

December 30, 2023

Study Completion

December 30, 2023

Last Updated

October 10, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)